CN115624604A - Traditional Chinese medicine composition for treating climacteric syndrome and depression and preparation method and application thereof - Google Patents
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Abstract
The invention relates to a traditional Chinese medicine composition for treating climacteric syndrome and depression, a preparation method and application thereof, wherein the traditional Chinese medicine composition is prepared from the following raw materials: lily, glossy privet fruit, cortex albiziae, lotus plumule, eclipta alba, radix curcumae, rhizoma acori graminei, dens draconis, light wheat and inula flower. Making into capsule, tablet, granule, etc. by conventional method. The medicinal preparation treats both principal and secondary aspects of climacteric depression, has no side effect, low price, simple and convenient preparation and wide application prospect.
Description
Technical Field
The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating climacteric syndrome and depression, and a preparation method and application thereof.
Background
The climacteric depression syndrome is a word which is continuously raised in the current society, the high-speed development of the society brings pressure to many people, the pressure cannot be released, and diseases such as depression and the like are finally caused, and the depression is an emotional state of the affective disorder. Affective disorders refer to a group of mental disorders with a marked and persistent change in mood (elevation or depression) as the underlying clinical manifestation, accompanied by corresponding abnormalities in thinking and behavior.
Climacteric syndrome (climacteric syndrome) refers to the symptoms of various organ systems and psychological syndrome caused by the mental psychology, neuroendocrine and metabolic changes in menopause. With age, female ovarian function declines, sex hormone secretion decreases, resulting in the increase of gonadotropin level, causing the balance of hypothalamus-pituitary-ovary axis to be disordered, thereby causing endocrine and autonomic nerve functional disorders. It is usually characterized by irritability, crying, sweating, dysphoria, vertigo, tinnitus, amnesia, palpitation, insomnia, menstrual disorder, arthralgia, etc. Males are associated with a deterioration in testicular function and a decrease in testosterone levels. Other factors such as genetics, environment, living habits, dietary patterns, individual constitutions, characters, presence or absence of mental stress, etc. are also closely related to the above.
At present, the pathogenesis of climacteric depression is not completely clarified and is in the stage of exploration. However, a great deal of research shows that the disease is possibly caused by the decrease of estrogen level, the dysfunction of neuroendocrine axes and the release of monoamine neurotransmitters, and scholars put forward academic ideas such as a cytokine hypothesis and a high glucocorticoid hypothesis.
The treatment of climacteric depression is mainly aimed at treating specific causes, and a better treatment effect can be obtained only by removing the root cause of the diseases. Although the clinical symptoms of patients can be relieved to a certain extent by western medicine treatment of climacteric depression in a short time, the western medicine has a plurality of defects in treatment of climacteric depression in a long term. For example: after being taken for a period of time, the traditional Chinese medicine composition can generate physical or psychological dependence, addiction, a large number of adverse reactions and potential carcinogenic risks; the clinical relapse rate is high after the withdrawal of the medicine, the compliance is poor, and the like, and the use of the medicine is disputed by multiple parties, thereby limiting the clinical application of the medicine. At present, the main using methods of western medicine are as follows: antidepressants, hormone replacement therapy, calcium agents and vitamin D therapy, but also behavioral therapies such as psychotherapy, aerobic exercise, and the like.
Disclosure of Invention
In view of the above, the invention provides a traditional Chinese medicine composition for treating climacteric syndrome and depression, and the traditional Chinese medicine composition has rich clinical experience and better treatment effect on treating climacteric depression and has unique advantages. Under the guidance of the theory of traditional Chinese medicine, the syndrome differentiation is more flexible, the medicine is safer, and the application prospect is wider. Also provides a preparation method and application of the traditional Chinese medicine composition.
According to the theory of traditional Chinese medicine, through continuous exploration of an inventor, the traditional Chinese medicine in the field is carefully screened by utilizing the unique property of the traditional Chinese medicine, and the formula of the traditional Chinese medicine composition for treating climacteric syndrome and depression is obtained, and the formula comprises the following components: lily, glossy privet fruit, cortex albiziae, lotus plumule, eclipta alba, radix curcumae, rhizoma acori graminei, dens draconis, light wheat, inula flower and auxiliary materials.
The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 3 to 10 portions of lily, 3 to 6 portions of glossy privet fruit, 3 to 6 portions of cortex albiziae, 1 to 1.5 portions of lotus plumule, 3 to 6 portions of eclipta alba, 3 to 5 portions of radix curcumae, 1.5 to 5 portions of rhizoma acori graminei, 7.5 to 15 portions of dens draconis, 7.5 to 15 portions of light wheat and 1.5 to 4.5 portions of inula flower.
The traditional Chinese medicine composition is preferably selected, and the preferable parts by weight are as follows: 10 parts of lily, 5 parts of glossy privet fruit, 5 parts of cortex albiziae, 1 part of lotus plumule, 5 parts of eclipta alba, 5 parts of radix curcumae, 5 parts of rhizoma acori graminei, 7.5 parts of dens draconis, 10 parts of blighted wheat, 2 parts of inula flower and auxiliary materials.
Wherein: the fructus Ligustri Lucidi is one of fructus Ligustri Lucidi processed with wine or fructus Ligustri Lucidi.
According to the traditional Chinese medicine theory, the pharmacological actions of the traditional Chinese medicines used in the prescription of the traditional Chinese medicine composition are as follows:
1. lily (alias: qianmei, zhongting, heavy box, mo Luo)
Sweet in flavor and slightly cold in nature
Meridian tropism: entering lung and heart
The functional indications are as follows: has the effects of nourishing yin, moistening lung, clearing away heart-fire and tranquilizing mind. It is mainly used for treating yin deficiency dry cough, cough with hemoptysis, insomnia and palpitation due to yin deficiency with heat, and heart-lung yin deficiency internal heat syndrome due to lily disease.
2. Fructus Ligustri Lucidi (alias: chinese ilex and glossy privet fruit)
Sweet and bitter in taste and cold in nature
Meridian tropism: entering liver and kidney meridians
The functional indications are as follows: has effects of nourishing liver and kidney, clearing heat and improving eyesight. Can be used for treating soreness of waist and knees, premature gray hair, yin deficiency with internal heat, hectic fever due to yin deficiency, night sweat, spermatorrhea, dizziness, blurred vision, amnesia, and tinnitus.
Liver-kidney yin deficiency syndrome: for dizziness, soreness and weakness of waist and knees, early white beard and hair due to liver and kidney yin deficiency, it can tonify liver and kidney singly, or combined with eclipta, and mulberry root added, it has more significant efficacy.
3. Cortex Albizziae (alias: dusk bark, evening primrose bark, cortex Albizziae)
Sweet in flavor and neutral in nature
Meridian tropism: meridian tropism for heart, liver and lung
The functional indications are as follows: has the effects of relieving depression, tranquilizing, promoting blood circulation, and relieving swelling. Is mainly used for treating restlessness, irritability, melancholy, dysphoria, insomnia, traumatic injury, fracture of tendons and bones, blood stasis, swelling and pain, pulmonary abscess, sore and carbuncle, pyogenic infections, and the like.
4. Lotus plumule (alias: job's tears, coix lacryma-jobi, lotus seed and lotus seed)
Bitter and cold taste
Meridian tropism: meridian entering heart and kidney
The functional indications are as follows: has effects of clearing heart fire, calming liver fire, stopping bleeding, and stopping nocturnal emission. It can be used for treating coma, delirium, dysphoria, insomnia, vertigo, conjunctival congestion, hematemesis, and spermatorrhea.
5. Ecliptae herba (alias: herba Lysimachiae foenumgraeci, alternanthera sessilis, eclipta alba)
Sweet and sour in flavor and cold in nature
Meridian tropism: entering liver and kidney meridians
The functional indications are as follows: has effects of nourishing liver and kidney, cooling blood, stopping bleeding, eliminating dampness and relieving itching. It can be used for treating dizziness, premature gray hair, kidney deficiency, toothache, hematemesis, hemoptysis, metrorrhagia, pudendal pruritus, whitish and turbid urine, and leucorrhea with red and white discharge.
Effects on the central nervous system: the eclipta has very obvious sedative and analgesic effects, and the total flavone effect of the eclipta is not as good as that of the total ingredients
6. Radix Curcumae (alias: ma 33921
Pungent, bitter and cold in nature
Meridian tropism: returning to the liver and gallbladder
The functional indications are as follows: has effects of promoting blood circulation, relieving pain, activating qi-flowing, resolving stagnation, clearing heart fire, cooling blood, promoting bile flow, and eliminating jaundice. Can be used for treating qi stagnation, blood stasis and pain, coma due to fever, epilepsy, phlegm retention, hematemesis, epistaxis, retrograde menstruation, hematuria, stranguria with blood, jaundice due to damp-heat in liver and gallbladder, and cholelithiasis.
7. Rhizoma Acori Graminei (alias: sword grass, acorus calamus and Acorus calamus)
Pungent and bitter with warm nature
Meridian tropism: the heart and stomach meridians entered
The functional indications are as follows: has effects of inducing resuscitation, eliminating dampness, regulating stomach function, tranquilizing mind, and benefiting mind. Mainly used for treating phlegm clouding the clear orifices and coma; dampness obstructing the middle energizer, fullness and distention in the stomach and abdomen, fullness and pain; dysentery with vomiting; amnesia, insomnia, tinnitus and deafness.
8. Dragon tooth
Sweet, astringent and cool in nature
Meridian tropism: the heart and liver meridians
The functional indications are as follows: has effects of relieving convulsion, tranquilizing, clearing heat, and relieving restlessness. It is mainly used for treating epilepsy due to convulsion, mania, palpitation, insomnia, dreaminess, fever, and vexation.
9. Blighted wheat (alias: float wheat)
Sweet taste and cool nature
Meridian tropism: meridian entered heart meridian
The functional indications are as follows: has the effects of consolidating superficial resistance, arresting sweating, invigorating qi and removing heat. It can be used for treating spontaneous perspiration, night sweat, fever due to yin deficiency, and bone-steaming and fatigue-heat.
10. Inula flower (alias: huang Shouhua, sunflower, marigold)
Pungent, salty and slightly warm in property
Meridian tropism: gui Fei
The functional indications are as follows: has the effects of lowering qi, eliminating phlegm, lowering adverse qi and relieving vomit. Can be used for treating cough, asthma, excessive phlegm, phlegm-fluid accumulation, fullness in chest and diaphragm, belching, emesis, chest and hypochondriac pain, etc.
Wherein:
matching cortex albiziae with lily: both of them are sweet in flavor and enter heart meridian, so they have the action of tranquilizing mind and are good at treating restlessness and insomnia due to deficiency. The silktree albizia bark Pi Xingping enters liver meridian, can nourish heart and calm mind, sooth liver and relieve depression, activate blood and cure carbuncle, and is used for uneasiness, depression and insomnia caused by emotional damage, traumatic injury, fracture, carbuncle, sore and swelling. Lily has slight cold nature entering lung channel, can clear heart and tranquilize mind, and nourish yin and moisten lung, and is mainly used for treating vexation and insomnia due to deficiency of heat in late stage of febrile disease and residual heat, internal injury miscellaneous diseases, vexation and palpitation due to yin deficiency with heat, chronic cough due to lung deficiency, dry cough and hemoptysis due to overstrain.
The yerbadetajo herb is matched with glossy privet fruit: the eclipta is sweet, sour and cold, and can nourish liver and kidney; the glossy privet fruit is sweet, bitter, cool and has the effect of nourishing the liver and the kidney. The two herbs are combined together to enhance the effect of nourishing liver and kidney. It is indicated for dizziness, blurred vision, early white beard and hair, soreness and weakness of waist and knees, etc. caused by deficiency of liver-yin and kidney-yin.
Rhizoma acori graminei and radix curcumae: rhizoma Acori Graminei has the effects of inducing resuscitation, dispersing qi, resolving stagnation, and eliminating dampness; radix Curcumae has effects of relieving liver qi stagnation, clearing away heart heat, cooling blood and removing blood stasis. The combination of the two can induce resuscitation, relieve depression, clear heart and refresh mind. It is indicated for phlegm obstruction of heart orifice and unclear consciousness due to febrile disease.
The medicine can be mixed with one or more pharmaceutically acceptable carriers to prepare any clinically or pharmaceutically acceptable dosage form, preferably oral preparation. When administered orally to a patient in need of such treatment, it can be formulated into conventional solid preparations or liquid preparations such as tablets, capsules, granules, etc.
On the basis, the inventor also provides a preparation method of the traditional Chinese medicine composition for treating climacteric syndrome and depression, which comprises the following steps: the raw materials in the formula are weighed according to the proportion, the conventional auxiliary materials are added, and the conventional medicinal preparation is prepared according to the conventional method.
Specifically, the method comprises the following steps: weighing the raw materials according to the proportion, decocting and extracting the raw materials by water, concentrating an extracting solution into an extract under reduced pressure, drying, crushing the extract into fine powder, adding conventional auxiliary materials, and preparing the conventional medicinal preparation according to a conventional method.
More specifically: weighing the raw materials in the formula according to the proportion, soaking the raw materials in 8-10 times of water for 30min, then boiling the raw materials for 10min by strong fire, decocting the raw materials for 1.5 h by slow fire for 2-3 times, 40-90 min each time, filtering, concentrating the filtrate under reduced pressure at-0.06-0.08 Mpa to obtain an extract with the relative density of 1.17-1.20 at 50-60 ℃, drying, crushing the extract into fine powder, adding conventional auxiliary materials, and preparing the conventional medicinal preparation according to a conventional method.
The pharmaceutical preparation comprises an oral liquid preparation and an oral solid preparation, wherein the oral solid preparation comprises granules, capsules and tablets.
The oral liquid formulation is prepared by: weighing the raw materials in the formula according to the proportion, soaking the raw materials in 8-10 times of water for 30min, boiling the raw materials for 10min by strong fire, decocting the raw materials for 2-3 times by slow fire for 1.5 h, decocting for 40-90 min each time, filtering, concentrating the filtrate under reduced pressure at-0.06-0.08 Mpa to obtain an extract with the relative density of 1.17-1.20 at 50-60 ℃, adding or not adding one or more of refined honey and sugar, uniformly mixing, and obtaining the oral liquid preparation, wherein the weight ratio of the total amount of auxiliary materials to the extract is 1:4-2:1.
The granules are prepared by: weighing the raw materials in the formula according to the proportion, soaking the raw materials in 8-10 times of water for 30min, then boiling the raw materials for 10min by strong fire, decocting the raw materials for 1.5 h by slow fire for 2-3 times, 40-90 min each time, filtering, concentrating the filtrate under reduced pressure at-0.06 to-0.08 Mpa to obtain an extract with the relative density of 1.17-1.20 at 50-60 ℃, drying, crushing the extract into fine powder, adding silicon dioxide, and adding or not adding one or more of dextrin and maltodextrin, uniformly mixing, wherein the weight ratio of the extract to the total amount of auxiliary materials is 1:2-2:1, granulating by a dry method or a wet method by using ethanol, drying, and the prepared granules can be directly used as granules.
The capsules are prepared by: weighing the raw materials in the formula according to the proportion, soaking the raw materials in 8-10 times of water for 30min, then boiling the raw materials for 10min by strong fire, decocting the raw materials for 1.5 h by slow fire for 2-3 times, 40-90 min each time, filtering, concentrating the filtrate under reduced pressure at-0.06-0.08 Mpa to obtain an extract with the relative density of 1.17-1.20 at 50-60 ℃, drying, crushing the extract into fine powder, adding silicon dioxide, and optionally adding one or more of dextrin and maltodextrin, uniformly mixing, wherein the weight ratio of the extract to the total amount of auxiliary materials is 1:2-2:1, performing dry granulation or wet granulation by using ethanol, drying, preparing granules, and filling the granules to prepare capsules.
The tablets are prepared by: weighing the raw materials in the formula according to the proportion, soaking the raw materials in 8-10 times of water for 30min, then boiling the raw materials for 10min by strong fire, decocting the raw materials for 1.5 h by slow fire for 2-3 times, 40-90 min each time, filtering, concentrating the filtrate under reduced pressure at-0.06 to-0.08 Mpa to obtain an extract with the relative density of 1.17-1.20 at 50-60 ℃, drying, crushing the extract into fine powder, adding silicon dioxide, adding or not adding one or more of dextrin and maltodextrin, uniformly mixing, wherein the weight ratio of the extract to the total amount of auxiliary materials is 1:2-2:1, granulating by a dry method or a wet method by using ethanol, drying, preparing granules, and tabletting the granules.
The inventor also provides an application of the traditional Chinese medicine composition in preparing a medicine for treating climacteric syndrome and depression.
The invention takes lily, glossy privet fruit, silktree albizzia bark, lotus plumule, eclipta alba, radix curcumae, rhizoma acori graminei, dens draconis, light wheat and inula flower as main materials and auxiliary materials as auxiliary materials, the medicines mutually assist, treat both symptoms and root causes, and play the effects of tonifying kidney and nourishing yin, removing dryness and soothing nerves, and nourishing nests and regulating menstruation. Researches show that the traditional Chinese medicine composition has the effects of increasing the secretion of estrogen, relieving the symptoms of irregular menstruation, flushing, palpitation, insomnia, hypodynamia, depression, excessive anxiety, unstable mood, irritability or depression, difficulty in concentration of attention and the like, and has a therapeutic effect on climacteric syndrome and depression caused by various reasons.
Detailed Description
The invention aims to provide a traditional Chinese medicine composition which can treat both symptoms and root causes, has small side effect, is safe and convenient and has low price. The traditional Chinese medicine aims to solve the problems of great toxic and side effects, easy relapse after medicine stopping and unobvious treatment effect of western medicines in the treatment of climacteric depression and achieve the purpose of treating both symptoms and root causes.
Based on the defects of the existing medicines for treating climacteric syndrome and depression, the inventor of the application collects the advantages of the majority of the families by researching the traditional Chinese medicines and combining with dialectical argumentation, finds an optimal treatment scheme, screens out natural traditional Chinese medicines for soothing the nerves and stabilizing the mind, tonifying deficiency and strengthening the body resistance from the medical treasury of China, extracts essence according to the formula of the theory of traditional Chinese medicine, and enables the natural traditional Chinese medicines to play the effects of clearing away heart-fire, nourishing yin and promoting the production of body fluid, and soothing the nerves and nourishing the heart.
In order to achieve the purpose, the technical scheme adopted by the invention is as follows:
a traditional Chinese medicine composition for treating climacteric syndrome and depression comprises lily, glossy privet fruit, cortex albiziae, lotus plumule, eclipta alba, radix curcumae, rhizoma acori graminei, dens draconis, blighted wheat, inula flower and auxiliary materials.
Specifically, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight:
3 to 10 portions of lily, 3 to 6 portions of glossy privet fruit, 3 to 6 portions of cortex albiziae, 1 to 1.5 portions of lotus plumule, 3 to 6 portions of eclipta alba, 3 to 5 portions of radix curcumae, 1.5 to 5 portions of rhizoma acori graminei, 7.5 to 15 portions of dens draconis, 7.5 to 15 portions of light wheat and 1.5 to 4.5 portions of inula flower.
The traditional Chinese medicine composition is preferably selected, and the preferable parts by weight are as follows: 10 parts of lily, 5 parts of glossy privet fruit, 5 parts of cortex albiziae, 1 part of lotus plumule, 5 parts of eclipta alba, 5 parts of radix curcumae, 5 parts of rhizoma acori graminei, 7.5 parts of dens draconis, 10 parts of blighted wheat, 2 parts of inula flower and auxiliary materials.
The preparation method comprises the following steps:
weighing the raw materials in the formula according to the proportion, soaking the raw materials in 8-10 times of water for 30min, boiling the raw materials for 10min by strong fire, decocting the raw materials for 1.5 h by slow fire for 2-3 times, 40-90 min for each time, filtering, concentrating the filtrate under reduced pressure at-0.06 to-0.08 Mpa to obtain an extract with the relative density of 1.17-1.20 at 50-60 ℃, drying, crushing the extract into fine powder, adding conventional auxiliary materials, and preparing the conventional medicinal preparation according to a conventional method.
Example 1
The formula is as follows: 20g of lily, 10g of wine glossy privet fruit, 10g of cortex albiziae, 2g of lotus plumule, 10g of eclipta alba, 10g of radix curcumae, 10g of rhizoma acori graminei, 15g of dens draconis, 20g of blighted wheat and 4g of inula flower
The process comprises the following steps: weighing the raw materials in the formula according to the proportion, soaking the raw materials in 8 times of water for 30min, then boiling the raw materials for 10min by strong fire, decocting the raw materials for 3 times by slow fire for 1.5 h, decocting for 60min each time, filtering, concentrating the filtrate under reduced pressure at-0.06 to-0.08 Mpa until the extract with the relative density of 1.17 to 1.20 at the temperature of 50 to 60 ℃, drying, crushing the extract into fine powder, adding silicon dioxide, adding dextrin and uniformly mixing, wherein the weight ratio of the extract to the total amount of auxiliary materials is 2:1. And (5) performing wet granulation to obtain the granular preparation. The obtained granules can also be filled into capsules or compressed into tablets.
The usage and dosage are as follows: taken with warm water, 1 bag each time, once in the morning and evening
Example 2
The formula is as follows: 6g of lily, 6g of glossy privet fruit, 6g of cortex albiziae, 2g of lotus plumule, 6g of eclipta alba, 6g of radix curcumae, 6g of rhizoma acori graminei, 12g of dens draconis, 10g of blighted wheat and 2g of inula flower
The process comprises the following steps: weighing the raw materials according to the proportion, soaking the raw materials in 10 times of water for 30min, boiling the raw materials for 10min by strong fire, decocting the raw materials for 2 times by slow fire for 40min each time, filtering, concentrating the filtrate under reduced pressure at-0.06 to-0.08 Mpa to obtain an extract with the relative density of 1.17 to 1.20 at 50 to 60 ℃, drying, crushing the extract into fine powder, adding silicon dioxide, adding dextrin, and uniformly mixing, wherein the weight ratio of the extract to the total amount of the auxiliary materials is 1:2. And (4) performing dry granulation to obtain the granular preparation. The obtained granules can also be filled into capsules or compressed into tablets.
The usage and dosage are as follows: taken with warm water, 1 bag each time, once in the morning and evening
Example 3:
the formula is as follows: 22g of lily, 12g of wine glossy privet fruit, 12g of silktree albizzia bark, 6g of lotus plumule, 12g of eclipta alba, 12g of radix curcumae, 12g of rhizoma acori graminei, 18g of dens draconis, 30g of blighted wheat and 6g of inula flower
The process comprises the following steps: weighing the raw materials in the formula according to the proportion, soaking the raw materials in 9 times of water for 30min, then boiling the raw materials for 10min with strong fire, decocting the raw materials for 3 times with slow fire for 1.5 h, decocting for 90min every time, filtering, concentrating the filtrate under reduced pressure at-0.06 to-0.08 Mpa to obtain an extract with the relative density of 1.17 to 1.20 at 50 to 60 ℃, adding refined honey or sugar, and uniformly mixing, wherein the weight ratio of the amount of the refined honey or sugar to the extract is 1:3. Thus obtaining the oral liquid preparation.
The usage and dosage are as follows: it is administered orally in the morning and evening of each day.
Example 4
The formula is as follows: 16g of lily, 8g of glossy privet fruit, 8g of cortex albiziae, 4g of lotus plumule, 8g of eclipta alba, 8g of radix curcumae, 8g of rhizoma acori graminei, 14g of dens draconis, 24g of blighted wheat and 3g of inula flower
The process comprises the following steps: weighing the raw materials in the formula according to the proportion, soaking the raw materials in 8 times of water for 30min, boiling the raw materials for 10min by strong fire, decocting the raw materials for 3 times by slow fire for 1.5 h, decocting the raw materials for 70min every time, filtering the decoction, and concentrating the filtrate under reduced pressure at the temperature of between-0.06 and-0.08 Mpa to obtain an extract with the relative density of between 1.17 and 1.20 at the temperature of between 50 and 60 ℃, thus obtaining the oral liquid preparation.
The usage and dosage are as follows: it is administered orally in the morning and evening of each day.
Example 5 toxicity test
Acute toxicity test: the acute toxicity test was carried out on 40 mice, each half of which had a body weight of 30-40 g. Mice were randomly divided into 2 groups, i.e., a control group and an administration group (the pharmaceutical preparation prepared in example 1), 20 mice in each group were fasted for 12 hours before the experiment, the pharmaceutical preparation prepared in example 1 of the present invention was administered to the administration group by dissolving in water and gavage (the single administration dose of gavage was 50g crude drug/kg), the control group was administered with an equal amount of physiological saline 2 times a day with an interval of 6 hours, and the mice were continuously observed for 14 days after administration, and the toxic reaction and the number of deaths were recorded. The experimental results show that: compared with a control group, the mice have no obvious difference after administration, and the mice have normal general conditions, diet, drinking water and weight increase after continuous observation for 14 days in the experiment. Therefore, the medicinal preparation has extremely low acute toxicity and safe clinical medication.
Long-term toxicity test: after the drug preparation prepared in the embodiment 1 of the invention is continuously applied to mice for 15 weeks and is stopped for 3 weeks, the results show that: the traditional Chinese medicine has no obvious influence on indexes such as hair, behaviors, excrement and urine, body weight, visceral weight, hemogram, liver and kidney functions, blood sugar, blood fat and the like of a mouse, and the visceral eye does not find out abnormal change and histological examination results show that after the traditional Chinese medicine is taken for 15 weeks and stopped for 3 weeks, all visceral organs of the mouse have no obvious change. The drug preparation has low toxicity after long-term administration to mice, has no abnormal reaction after drug withdrawal, and is safe to apply.
Example 6 pharmacodynamic study
1. Purpose of experiment
The influence of the medicine on rat climacteric syndrome is observed by adopting an ovariectomized rat in combination with a depression model so as to determine the effect of improving climacteric depression.
2. Experimental Material
2.1 Experimental animals
70 healthy SD female rats, 200-220g, SPF grade, purchased from Beijing Huafukang Biotech, inc., license number: scxk (Kyoto) 2019-0008.
2.2 test drugs
The Chinese medicinal composition granules (prepared by the method of the embodiment 1 of the invention) are equivalent to 6.49g of crude drugs per gram of medicinal powder.
2.3 Positive drugs
Kunbao Wan, beijing Tongrentang GmbH, specification: the pill weight of each 100g is 10g, and the clinical daily dosage is 10g.
2.4 reagents
Pentobarbital, MERCK, batch number: p11011.
Penicillin sodium for injection, north china pharmaceutical products ltd, lot number: F0092102.
3. experimental methods
3.1 method for preparing medicine
(1) The preparation method of the tested medicine comprises the following steps:
weighing 6.3g of tested medicine, adding purified water to 90ml for dissolving to obtain high-dose group solution;
taking 40ml of the high-dose group solution, adding purified water to 80ml, and uniformly mixing to obtain a medium-dose solution;
30ml of the medium dose group solution was taken, and purified water was added to 60ml to obtain a low dose group solution.
The administration was by intragastric administration at 2ml/100g body weight. The administration dosage of the high, medium and low dosage groups is respectively 9.10g crude drug/kg, 4.55g crude drug/kg, 2.275g crude drug/kg.
(2) The preparation method of the positive medicine comprises the following steps:
grinding the pill, and dissolving in water to obtain 45mg/ml solution. The administration volume was 2ml/100g body weight. The test dose of rats was 0.9g/kg.
3.2 grouping, molding and administration
70 female rats are bred adaptively for 3 days, except 10 animals in a normal group and a sham operation group respectively, the rest animals are anesthetized by intraperitoneal injection of 2% pentobarbital, the abdomen of the rat is cut open, the ovario fallopian tube (including fat) is firstly ligated, ovaries on two sides are removed after ligation, the uterus is sent back to the abdominal cavity along the trend after operation, and then the wound is sutured layer by layer. In the sham group, the uterus was removed and returned to the abdominal cavity without ovariectomy. Penicillin was injected continuously 3 days after the operation, 1 time per day, to prevent wound infection. Carrying out observation on a rat vaginal smear after modeling for one week, wherein no keratinocyte or only a small amount of keratinocyte is observed continuously for 5 days, indicating that ovariectomy is successful, indicating that the animal basically accords with climacteric performance, randomly dividing the successfully modeled animals into a model group, a high-dose group, a medium-dose group, a low-dose group and a positive medicine group, and carrying out unpredictable stress treatment on each group: rats were kept in 1 litter per cage and stimulated for 7 days (1) with cage tilting (45 °) (2)4 ℃ cold water swimming 5 min), (3) with padding 24h (4) without water (24h), (5) with tail clamping 1min (1 cm from tail) (6) without food (24h), (7) shaking, and stimulation was performed for 21 days, one of which was randomly selected daily. The administration was started simultaneously with the stimulation, and the respective test drugs were administered in a body mass of 20ml/kg for 4 weeks. Normal, model, sham groups were given equal volumes of distilled water.
3.3 test methods
A sugar water preference test is carried out after 21 days of continuous stimulation, 1 bottle of pure water and one bottle of water containing 1 percent of cane sugar are placed in a cage before the test, the water in the two bottles is replaced after 12 hours, and the rat freely drinks the sugar water for 24 hours. After 24h without fasting but water deprivation, 150ml of pure water and 150ml of 1% sucrose water were placed in each cage, after 2h, two bottles of water were exchanged, the intake of pure water and sucrose water for 4h rats was recorded, and the sugar water preference (ratio of sugar water consumption to total liquid consumption) was calculated.
The forced swimming test was performed the next day after the sugar water preference test, and the rats were placed in a cylindrical bucket having a height of 50cm and a diameter of 20cm, and the water depth was about 40cm. Forced swimming was performed for 6min in total, the first 2min was the adaptation time, the last 4min was the observation time, and the time that the rat was standing in water was recorded (stop struggling, floating still, front paw still or slightly stroking to keep body from sinking).
After the last administration for 1h, 2% pentobarbital is injected into the abdominal cavity for anesthesia, and blood and hippocampus are taken for relevant index detection.
3.4 statistical processing method
Data sheet mean. + -. Standard deviation
Showing that the data are tested by SPSS 21.0 software, and statistical treatment is carried out by independent sample Mann-Whitney U test in nonparametric statistics, and P is used for all<0.05 was statistically significant as a difference.
4. Results of the experiment
The tested medicine has influence on the sugar water drinking amount of rats with climacteric depression of ovariectomized rats. The results are shown in Table 1.
TABLE 1 influence of sugar water consumption in rats with menopausal depression in ovariectomized rats: (
n＝10)
P <0.05 in the medium dose group compared to the model group; the P of the model group was <0.05 compared to the control group.
Compared with a control group, the sugar water drinking rate of the model group is obviously reduced (P < 0.05); compared with the model group, the sugar water drinking rate of the medium-dose group is obviously increased in the test drug administration group (P < 0.05).
The influence of the tested medicament on the forced swimming time of the rats with the menopausal depression of the ovariectomized rats. The results are shown in Table 2.
TABLE 2 Effect on forced swimming time of rats with menopausal depression due to ovariectomy: (
n＝10)
Comparing the middle dose group, the positive drug group and the model group, wherein P is less than 0.05; the P of the model group was <0.05 compared to the control group.
Compared with a control group, the forced swimming stillness time of the rats in the model group is obviously increased (P < 0.05); compared with the model group, the forced swimming stillness time of rats in the dose group and the positive drug group in the tested drug is obviously increased (P < 0.05).
The tested medicine has influence on the content of neurotransmitter in hippocampus tissue of rats with climacteric depression of ovariectomized rats. The results are shown in Table 3.
TABLE 3 Effect on hippocampus tissue neurotransmitter content: (
n＝10)
HT (5-hydroxytryptamine), 5-HIAA (5-oxindole acetic acid), DA (dopamine), GABA (gamma-aminobutyric acid).
* P <0.05 compared to model group; Δ P <0.05 compared to control.
Compared with a control group, the hippocampus of a model group rat has obviously reduced 5-HT, 5-HIAA, DA and GABA (P < 0.05), compared with the model group, the hippocampus of a test drug high-dose group has obviously increased 5-HT, 5-HIAA, DA and GABA (P < 0.05), the hippocampus of a middle-dose group has obviously increased 5-HIAA and GABA (P < 0.05), the hippocampus of a low-dose group has obviously increased 5-HT and GABA (P < 0.05), and the hippocampus of a positive drug has obviously increased 5-HT, 5-HIAA and GABA (P < 0.05).
The tested medicine has influence on the contents of Follicle Stimulating Hormone (FSH), luteinizing Hormone (LH) and Corticosterone (CORT) in rat serum with climacteric depression of ovariectomized rats. The results are shown in Table 4.
TABLE 4 Effect on serum FSH, LH, CORT levels in rats with menopausal depressive symptoms in ovariectomized rats: (
n＝10)
* P <0.05 compared to model group; Δ P <0.05 compared to control.
Compared with a control group, the blood requirement of rats in the model group is obviously reduced (P < 0.05), FSH and LH are obviously increased (P < 0.05), and compared with the model group, the blood serum of the tested drug in the high, medium and low dose groups and the positive drug group is obviously increased (P < 0.05), and the blood serum of the FSH and LH is obviously reduced (P < 0.05).
The research result indicates that the tested medicine has the function of improving the climacteric depression.
Example 7 concrete cases
Wang some, woman, 51 years old.
The main complaints are: depressed mood with insomnia and dreaminess for half a year.
The symptoms are as follows: the whole day is low in mood and often has feelings of inferior quality, conscientiousness and guilt; insomnia, uneasiness to fall asleep, dreaminess and easy wakening; accompanied by dizziness, amnesia, hypodynamia, soreness and weakness of the waist and knees, and sweating due to heat. Poor appetite, occasional abdominal distension, dark and gloomy complexion, good appetite and easy conditioning. Irregular menstruation lasts for nearly one year and stops menstruation for 2 months. A dark red tongue with thin and yellow coating and a wiry and thready pulse.
Scale scoring: HAMD score 28 points, moderate depression, kupperman score 35 points.
And (3) Western diagnosis: climacteric depression
Traditional Chinese medicine diagnosis: perimenopausal depression syndrome of liver-yin and kidney-yin deficiency.
Therapeutic principle: nourishing liver and kidney, resolving stagnation and tranquilizing.
Treatment: the Chinese medicinal composition granules are taken with warm water twice a day in the morning and at night, 1 bag is taken each time, and the treatment is carried out for 4 weeks.
Through treatment, the mood of the patient is lowered and obviously improved, the self-inferior, the self-conscientiousness and the guilt feelings disappear, the working state is good during work, and the patient actively participates in social activities or parties; the sleep quality is improved, and the people occasionally wake up; the sweating disappeared after heating. Poor appetite, abdominal distention, dizziness, amnesia, asthenia, and soreness of the waist and knees. The HAMD score reduction value is checked again for 8 points, the Kupperman score is checked for 15 points, the liver and kidney function is not obviously abnormal, and the curative effect judgment is obvious.
EXAMPLE 8 clinical experiments
1. Study object
140 cases of female climacteric depression patients who are seen in outpatient service of drumbeat traditional Chinese medicine hospitals are collected and randomly grouped to carry out clinical experiments of the traditional Chinese medicine composition. The selected cases all accord with the diagnosis standard of perimenopausal syndrome diagnosis in the gynecology and obstetrics (Beijing: 2008 edition of people's health publishing agency), and the diagnosis standard of the third edition (CCMD-3) of Chinese mental disease classification and diagnosis standard, and HAMD scoring (rating scale scoring is more than or equal to 21 points) is carried out at the same time, and the syndrome differentiation accords with the diagnosis standard of ' depression syndrome ' in the standard of curative effect of diagnosis of traditional Chinese medical symptoms and the standard of ' syndrome differentiation of symptoms before and after menopause ' formulated in the standard of traditional Chinese medical science. The general data collection is carried out on female climacteric depression patients meeting the selection standard, wherein the general data comprises the age, the reproductive endocrine hormone level and the like of the patients, and the data such as the age, the HAMD score, the Kupperman score, the PSQI, the reproductive endocrine hormone level and the like among groups are determined and are statistically comparable.
2. Method of treatment
According to the declaration, design and implementation of the subject of medical scientific research, 140 patients are randomly divided into treatment groups and control groups by a random digital method, and 70 patients in each group are treated. Flupentixol melitracen tablets (Denmark Lingbei pharmaceutical Co., ltd., national Standard, size: 0.5mg, 0.0 mg; 20 tablets) were administered orally to the control group, 1 tablet each in the morning after lunch, and were continuously administered for 4 weeks. Treatment groups: the Chinese medicinal composition granules are taken with warm water, 150ml of the Chinese medicinal composition is taken once in the morning and at night every day, and the Chinese medicinal composition granules are continuously taken for 4 weeks.
3. Effect evaluation criterion
The HAMD scale was used as the primary index for assessing the severity of depression before and after treatment; the improvement rate of the traditional Chinese medicine symptom integral, the Kupperman score and the PSQI score are adopted to evaluate the improvement condition of the climacteric symptoms as a secondary evaluation standard. Calculating the formula: fraction reduction = (total fraction before treatment-total fraction after treatment)/total fraction before treatment × 100%. According to the nationally uniform class 4 standard, the following are:
and (3) healing: the percentage of HAMD reduction is more than or equal to 75 percent
The effect is shown: the reduction rate of HAMD is more than or equal to 50 percent
The method has the following advantages: the reduction rate of HAMD is more than or equal to 25 percent
And (4) invalidation: the decreasing rate of HAMD is less than 25 percent
Total effective rate = recovery + significant effect + effective
4. Results of the experiment
The results of early clinical studies show that the total effective rate of the treatment group is 84.4 percent, and the total effective rate of the control group is 59.4 percent. The difference was statistically significant (P < 0.05).
Two of the patients had a change in HAMD score compared: the HAMD scores of the treatment groups are respectively 25.09 +/-2.89 points and 14.72 +/-2.95 points before and after treatment; the HAMD scores of the control group are 25.63 +/-3.42 points and 18.53 +/-3.53 points before and after treatment respectively, and the difference has statistical significance. The Kupperman score and the PSQI score of two groups of patients are compared with the change conditions before and after the traditional Chinese medicine syndrome integral treatment, and the t-test difference of the two samples has statistical significance. Comparison of the changes in serum reproductive hormone levels in two groups of patients showed that the differences before and after treatment with E2 and FSH were statistically significant. No adverse reaction
The traditional Chinese medicine components adopted by the invention are compatible with each other, the synergistic treatment effect can be exerted, the components of the used traditional Chinese medicine raw materials have the efficacy of mutual interweaving and mutual promotion and coordination, and clinical verification proves that the traditional Chinese medicine has good treatment effect on climacteric depression.
Details of embodiments of the present invention will be readily apparent to those skilled in the art, and the present invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The present embodiments are to be considered as illustrative and not restrictive, and all changes coming within the meaning and equivalency range of the appended claims are intended to be embraced therein.
Claims (9)
1. A traditional Chinese medicine composition for treating climacteric syndrome and depression is characterized by comprising lily, glossy privet fruit, cortex albiziae, lotus plumule, eclipta alba, radix curcumae, rhizoma acori graminei, dens draconis, light wheat, inula flower and auxiliary materials.
2. The traditional Chinese medicine composition for treating climacteric syndrome and depression according to claim 1, wherein the traditional Chinese medicine composition comprises, by weight, 3-10 parts of lily, 3-6 parts of glossy privet fruit, 3-6 parts of cortex albiziae, 1-1.5 parts of lotus plumule, 3-6 parts of eclipta alba, 3-5 parts of radix curcumae, 1.5-5 parts of rhizoma acori graminei, 7.5-15 parts of dens draconis, 7.5-15 parts of blighted wheat, 1.5-4.5 parts of inula flower and auxiliary materials.
3. The traditional Chinese medicine composition for treating climacteric syndrome and depression according to claim 2, wherein the traditional Chinese medicine composition comprises, by weight, 10 parts of lily, 5 parts of glossy privet fruit, 5 parts of cortex albiziae, 1 part of lotus plumule, 5 parts of eclipta alba, 5 parts of radix curcumae, 5 parts of rhizoma acori graminei, 7.5 parts of dens draconis, 10 parts of blighted wheat, 2 parts of inula flower and auxiliary materials.
4. The traditional Chinese medicine composition for treating climacteric syndrome and depression as claimed in any one of claims 1 to 3, wherein said fructus Ligustri Lucidi is one of wine fructus Ligustri Lucidi or fructus Ligustri Lucidi.
5. The preparation method of the traditional Chinese medicine composition for treating climacteric syndrome and depression as claimed in any one of claims 1 to 3, wherein the raw materials in the formula are weighed according to the proportion, the conventional auxiliary materials are added, and the traditional Chinese medicine composition is prepared into the conventional pharmaceutical preparation according to the conventional method.
6. The preparation method of the traditional Chinese medicine composition for treating climacteric syndrome and depression as claimed in claim 5, wherein the raw materials in the formula are weighed according to the proportion, decocted with water for extraction, the extract is concentrated under reduced pressure into extract, dried, crushed into fine powder, added with conventional auxiliary materials, and prepared into conventional pharmaceutical preparations according to a conventional method.
7. The preparation method of the traditional Chinese medicine composition for treating climacteric syndrome and depression as claimed in claim 6, wherein the raw materials in the formula are weighed according to the proportion, soaked in water of 8-10 times of the amount of the raw materials for 30min, boiled with strong fire for 10min, simmered for 1.5 h, decocted for 2-3 times, each time for 40-90 min, filtered, and the filtrate is decompressed and concentrated to an extract with a relative density of 1.17-1.20 at 50-60 ℃ under-0.06-0.08 Mpa, dried, crushed into fine powder, added with conventional auxiliary materials, and prepared into a conventional pharmaceutical preparation according to a conventional method.
8. The preparation method of the traditional Chinese medicine composition for treating climacteric syndrome and depression according to claim 7, wherein said pharmaceutical preparation comprises oral liquid preparation and oral solid preparation, wherein the oral solid preparation comprises granules, capsules and tablets.
9. The use of the Chinese medicinal composition for the treatment of climacteric syndrome and depression according to any one of claims 1 to 3, wherein the use of the Chinese medicinal composition in the preparation of medicament for climacteric syndrome and depression.
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